Biopharmaceutical companies Bristol-Myers Squibb Company (BMY) and AstraZeneca Plc (AZN, AZN.L) announced Wednesday that the US Food and Drug Administration has accepted for review a New Drug Application for an investigational fixed dose combination of Onglyza and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.
Onglyza, or saxagliptin, is a dipeptidyl peptidase-4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The companies had submitted the NDA with the FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.
The NDA is based on bioequivalence data and data from Onglyza phase 3 clinical trial program, which included studies for co-administration of Onglyza and immediate release metformin, as an adjunct to diet and exercise, in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naïve adult patients.
Most common adverse reactions with Onglyza were upper respiratory tract infection, headache, nasopharyngitis and urinary tract infection.
In January 2007, New York-based Bristol-Myers Squibb and AstraZeneca entered into a collaboration to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes.
BMY is currently trading on the New York Stock Exchange at $25.80 per share, down $0.19 or 0.73%, on a volume of 3.96 million shares. In the past 52-week period, the stock has been trading in a range of $18.83 to $26.62.
AZN is currently trading on the London Stock Exchange at 2,906.50 pence per share, up 4.50 pence or 0.15%, on a volume of 1.94 million shares. In the past 52-week period, the stock has been trading in a range of 2,228.00 pence to 3,136.00 pence.
AZN is currently trading on the NYSE at $44.58 per share, up $0.19 or 0.43%, on a volume of 231,463 shares. In the past 52-week period, the stock has been trading in a range of $32.22 to $50.70.
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